Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- plasma concentration of drugs fentanyl and propofol
研究概览
简要总结
The primary objective of this study is to determine the influence of insulin resistance on drug metabolism and response in obese subjects. The investigators hypothesize that expression of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin gene can predict the insulin resistance and drug response among obese subjects.
详细描述
The following study will hypothesizes that insulin resistance causes changes in drug metabolism, elimination, and effect. We will differentiate the insulin resistant phenotype amongst obese individuals on the basis of both laboratory (fasting insulin, triglycerides, fasting glucose) analysis, and quantitative and qualitative adiponectin expression. We will determine the effect of insulin resistance on the pharmacokinetics and pharmacodynamics of anesthetic induction agents and opioids, using propofol and fentanyl as examples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include patients of adult age
- •American Society of Anesthesiologists Class I, II, or III, and undergoing elective surgical procedures requiring general anesthesia
- •Body mass index greater than 35
排除标准
- •Patients with evidence of hepatic, renal, or cardiovascular dysfunction
- •History of difficult tracheal intubation, or adverse reaction to anesthesia shall be excluded from the study
- •Patients taking prescribed or over-the-counter anxiolytics, narcotics, or sleeping aids, will also be excluded
研究组 & 干预措施
Propofol and Fentanyl administration
Propofol and Fentanyl will be administered to all subjects. All subjects will have blood drawn to determine pharmacokinetic variables. Processed EEG will be used to determine pharmacodynamics. Plasma samples will be used to ascertain adiponectin levels and for DNA sampling for analysis of adiponectin single nucleotide polymorphisms.
干预措施: Propofol and Fentanyl administration (Drug)
结局指标
主要结局
plasma concentration of drugs fentanyl and propofol
时间窗: measured for 12 hours (beginning of anesthesia to 12 hours after)
Plasma concentration over time will be measured and modeled in order to calculate drug clearance, volume of distribution, area under the curve, and micro rate constants. Knowledge of these variables will allow safer administration of anesthetic drug administration in the obese population.
次要结局
- Adiponectin plasma protein levels(measured once (immediately before the operation))
- Adiponectin gene polymorphisms(measured once per study (immediately before the operation))
研究者
Jerry Ingrande
Instructor
Stanford University